A Joint Clinical Assessment (JCA) refers to a coordinated evaluation of the clinical evidence of a medicine’s efficacy, safety, and therapeutic value, conducted by multiple health technology assessment (HTA) bodies across Europe. This process aims to streamline and harmonize the assessment procedures, ensuring that all participating countries have access to consistent and high-quality clinical evaluations.… Continue reading Joint Clinical Assessments: Harmonizing Medicine Evaluations Across Europe Under EMA Regulations
Tag: Clinical Trials
Process for Health Technology Assessments (HTAs) in Germany
Health Technology Assessments (HTAs) in Germany are essential to evaluating the benefits, risks, and economic implications of medical technologies and interventions. The process involves several key institutions. These bodies have distinct roles in evaluating and deciding on the inclusion and reimbursement of health technologies within the healthcare system. Before looking at the process, let’s explore… Continue reading Process for Health Technology Assessments (HTAs) in Germany
Exploring Emulated Clinical Trials: Bridging the Gap Between RCTs and Real-World Evidence
Randomized clinical trials (RCTs) represent the most rigorous and robust research method for determining whether a cause–effect relation exists between an intervention and an outcome. However, RCTs are costly, slow, and often impractical to generate evidence for many important research questions. In the evolving landscape of healthcare research, the concept of emulated clinical trials… Continue reading Exploring Emulated Clinical Trials: Bridging the Gap Between RCTs and Real-World Evidence
External Control Arms in Clinical Trials: Case Studies of Health Authority Submissions
In recent years, the landscape of clinical trials has been evolving, with innovative methodologies gaining traction. One of such advancement is the use of External Control Arms (ECAs) in clinical trials. ECAs utilize existing patient data external to the planned clinical trial as a comparison group. An ECA can be constructed using data from… Continue reading External Control Arms in Clinical Trials: Case Studies of Health Authority Submissions
Common Data Models in Clinical Research
In clinical research, data models are essential for organizing, storing, and analyzing complex healthcare data. Effective data modeling ensures accurate data integration, facilitates efficient data analysis, and enhances data sharing across different systems and studies. Let’s explore some of the most commonly used data models in clinical research and their applications. 1. CDISC Standards… Continue reading Common Data Models in Clinical Research